U-Amgen namuhla umemezele ukwethulwa kokusebenza ngempumelelo nedatha yokuphepha evela ocwaningweni lwe-CodeBreaK 100 Phase 1/2 ezigulini ezinomdlavuza we-pancreatic othuthukisiwe we-KRAS G12C ezithole i-LUMAKRAS® (sotorasib). Idatha izokwethulwa ku-American Society of Clinical Oncology (ASCO) Plenary Series yanyanga zonke ngo-Feb. 15, 2022. Idatha ibonisa umsebenzi wokulwa nomdlavuza okhuthazayo futhi onenjongo ngokomtholampilo kanye nenzuzo enhle:iphrofayili yengozi.
"Ngokusekelwe kule datha ejabulisayo, sandisa i-CodeBreaK 100 ukuze sibhalise iziguli eziningi ezine-pancreatic nezinye izinhlobo zesimila ukuze ziqonde kangcono ukusebenza nokuphepha kwe-LUMAKRAS kumathumba angaphandle kwamangqamuzana amaphaphu kanye nomdlavuza we-colorectal okungewona amancanyana," kusho uDavid M. Reese. , MD, iphini likamongameli omkhulu wezoCwaningo Nokuthuthukiswa kwa-Amgen. “I-CodeBreaK iwuhlelo olukhulu nolubanzi kakhulu lwesilingo somtholampilo emhlabeni wonke kuze kube manje olunohlu lwedatha oluqine kakhulu, olubuyekezwe phakathi nendawo. Njengoba sifunda okwengeziwe kudatha ebanzi esiyiqoqayo, sizoqhubeka nokutshala imali ohlelweni ngokwandisa amaqoqo futhi sihlole izinhlanganisela ezintsha ukuze sisize iziguli eziningi ngangokunokwenzeka.”
I-LUKRAS ikhombise izinga lokuphendula lenhloso eliqinisekisiwe eliphakathi nendawo (ORR) lama-21% kanye nezinga lokulawulwa kwezifo (DCR) lama-84% kuzo zonke iziguli ezingama-38 ezilashwe kakhulu ngaphambili zomdlavuza we-pancreatic. Cishe ama-80% eziguli athola i-LUMAKRAS njengokwelashwa komugqa wesithathu noma kamuva. Iziguli eziyisishiyagalombili kwezingama-38 zithole ukusabela okuyingxenye okuqinisekisiwe (PR) okwenziwe ukubuyekezwa okuzimele okuphuphuthekile (BICR). Iziguli ezimbili kweziyisishiyagalombili ezine-PR zinezimpendulo eziqhubekayo. Isikhathi esimaphakathi sokuphendula sasiyizinyanga ezingu-5.7 nokulandelela okumaphakathi kwezinyanga ezingu-16.8 kusukela ngosuku lokunqanyulwa kwedatha lwangomhla kaNov. 1, 2021. Imiphumela iphinda ibonise ukusinda kwamahhala kwe-median progression (PFS) yezinyanga ezingu-4 kanye nokusinda okuphelele okumaphakathi ( OS) cishe izinyanga eziyi-7. Azikho izimpawu ezintsha zokuphepha ezihlonziwe ngalolu cwaningo lweziguli ezinomdlavuza we-pancreatic osezingeni eliphezulu. Izenzakalo ezimbi ezihlobene nokwelashwa (TRAEs) zanoma yiliphi ibanga zenzeke ku-16 (42%) iziguli ezihudo (5%) nokukhathala (5%) njengebanga elivame kakhulu le-TRAEs ye-3. Awekho ama-TRAE abulele noma aholele ekuyekisweni kokwelashwa.
"Ngemuva kwamashumi eminyaka ocwaningo, ukwelashwa kwamanje kweziguli ezinomdlavuza we-pancreatic kunikeza izinzuzo ezilinganiselwe zokusinda, okubonisa isidingo esibalulekile sezinketho zokwelapha ezinoveli, eziphephile nezisebenzayo," kusho uJohn Strickler, uprofesa ohlangene we-MD wezokwelapha, i-Duke University School of Medicine kanye ne-oncologist yamathumbu. . "Kudathasethi enkulu kunazo zonke ehlola ukusebenza nokuphepha kwe-KRASG12C inhibitor kumdlavuza we-pancreatic olashwe kakhulu, i-sotorasib ithole izinga lokuphendula eliqinisekisiwe eliphakathi nendawo elingu-21% kanye nezinga lokulawula izifo lama-84%. Lokhu kunengqondo ezigulini ngoba alukho uhlobo lokwelapha olujwayelekile lwalezi ziguli uma sezifinyelele emgqeni wesithathu wokwelashwa.”
Umdlavuza wamanyikwe uyisifo esiyingozi kakhulu. Kuyimbangela yesine ehamba phambili yokufa okuhlobene nomdlavuza kubo bobabili abesilisa nabesifazane e-US ngezinga lokusinda leminyaka emi-5 elicishe libe ngu-10%. Kunesidingo esikhulu esingafinyeleleki seziguli ezinomdlavuza we-pancreatic othuthukile osethuthuke ngemva kokwelashwa komugqa wokuqala, lapho ukwelashwa komugqa wesibili okugunyazwe yi-FDA kunikeze ukuphila cishe izinyanga eziyisithupha kanye nezinga lokuphendula lika-16%. Ngemuva kokuqhubekela phambili ku-chemotherapy yomugqa wokuqala nowesibili, awekho amakhambi anenzuzo ebonisiwe yokusinda. Naphezu kwentuthuko ekwelashweni, intuthuko embalwa eyenziwe ukuze kuthuthukiswe ukuhlonzwa nokwelashwa komdlavuza we-pancreatic.
Kulinganiselwa ukuthi cishe u-90% weziguli ezinomdlavuza we-pancreatic ziphethe ukuguqulwa kwe-KRAS nge-KRAS G12C ebalwa cishe ku-1-2% walokhu kuguqulwa.
